THOUSANDS of Brits who’ve undergone back surgery could need to go under the knife again to remove bone-destroying implants banned by the NHS.
An urgent safety alert was issued earlier this year to patients who’d had M6-C artificial disc implants fitted in their spine.
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M6-C artificial disc implants have been linked to bone lossCredit: Refer to Source
Sophia Harrison had a spinal implant fitted in 2019 and has experienced side effects Credit: PA
The device, designed to replace damaged cervical discs, was removed from worldwide sale after it was found to break down bone tissue.
The device is no longer in use in the UK and patients were called for urgent x-rays.
Sophia Harrison, 52, developed a serious infection and 10cm abscess in her spine after having the implant fitted seven years ago.
She now faces “daunting” operations to remove the device and correct the damage to her spine.
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Lawyers fear Sophia may be one of thousands of Brits needing complex surgery as a result of having M6-C artificial disc implants fitted.
Sophie said: “I am so angry that we weren’t told about the faults of the disc that leads to bones disintegrating.
“It’s absolutely despicable as the manufacturer would have known about this so why has it taken so long?
“If I had known earlier, the infection would have been caught and I would not be facing what has now become such complex and daunting surgeries on my spine.”
Sophia Harrison had the implant fitted seven years ago and went on to develop a serious infection Credit: PA
Lawyers fear she may be one of thousands Credit: Getty
The M6-C artificial disc implant was designed to replace damaged discs in the neck and offered to patients an alternative to spinal fusion surgery, which involves placing metal rods in the spine.
However, the implant has been linked to osteolysis, a progressive condition where bone tissue is destroyed and resorbed by the body.
Device manufacturer Orthofix announced it would discontinue the M6-C disc in February 2025.
Law firm Penningtons Manches Cooper said it has been contacted by at least 10 people who have had the implant, with lawyers concerned that thousands more could be affected.
It is now exploring if a legal claim is possible against the manufacturer.
Sophia, from East Grinstead, East Sussex, had the implant fitted in 2019.
Two years later, she went to see her surgeon complaining of pins and needles in her hands.
Around the same time, she noticed a lump in her throat that was impacting her voice and ability to swallow.
Sophia, who works in corporate communications, said she did not realise the two issues were connected.
After receiving a letter from the Medicines and Healthcare products Regulatory Agency (MHRA), she went for a CT scan to be checked for osteolysis.
It showed a large mass, which turned out to be a 10cm abscess.
Sophia recalled: “My doctor said he nearly fell off his chair looking at the results, as the infection continued to grow despite being drained.
“I can feel it growing again by the day and I’ve now been told they may have to take out two further discs along with the implant and insert a metal rod.
“I’m speaking out as I want to raise awareness and tell people who have this implant to have a scan as soon as they can so that they can avoid what is happening to me.
“You may not even be aware you have an associated infection or other symptoms.
“I feel for all of the surgeons who are having to clear up the mess of the previous doctors who inserted these implants into patients.”
Australian regulators had issued a hazard alert due to concerns about bone loss associated with the M6-C disc in 2020.
However, UK patients were not updated until six years later.
In January, the MHRA flagged that patients with the device may face a risk of osteolysis and said those with the implant should have annual routine monitoring.
Lyndsey Skibinski, a specialist medical negligence solicitor at Penningtons Manches Cooper – who is advising Sophia and leading the investigation for other implant patients, said: “This is a potentially huge public health issue with thousands of patients affected.
“Most of the people approaching us have had the implant in place for between eight and nine years but it is crucial that anyone who has this implant gets a scan to identify any problems and continues with recommended annual monitoring.
“Many will need complex surgery to remove the implants which poses the risk of paralysis or long term chronic pain.
“We are currently investigating the legal options open to those we are advising to see how we can secure justice for the trauma and suffering they are experiencing and also to recover funding for future treatment and rehabilitation.”
Dr Stephanie Millican, deputy director of benefit risk evaluation at the MHRA, said the regulator started an investigation into the M6-C device following reports in early 2025.
“The MHRA took these concerns seriously and found that there was a delay in the manufacturer’s communication of the risks of osteolysis to users and patients in the UK,” she said.
“Patient safety is our top priority. We continuously monitor medical devices used in the UK to ensure they perform to the expected standards.
“The MHRA has advised healthcare professionals that patients implanted with the M6-C artificial cervical disc should be informed of the risks of osteolysis, receive annual routine monitoring and discuss the need for further investigation and continued follow-up.
“Patients who have an M6-C device implanted should expect to be contacted by their surgeon or implanting hospital.
“We encourage patients, carers and healthcare professionals to report any suspected side effects to the MHRA via the Yellow Card scheme.”
